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Completed

NCT Number: NCT01212874

Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery

This is an investigator initiated, sponsored, open label, prospective randomized controlled trial to be performed in adult patients undergoing scheduled cardiac surgery. Patients will be randomized to esmolol infusion or nitroglycerin infusion for control of hypertension that occurs during cardiac surgery from induction of anesthesia to initiation of cardiopulmonary bypass (CPB).

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92354, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients scheduled for cardiac surgery at LLUMC University Hospital will be eligible for participation in this study.

Exclusion criteria

  • severe LV (left ventricle)dysfunction (EF < 35%).
  • emergency procedures.
  • procedures with combined carotid artery surgery.
  • patients at high risk for stroke.
  • hemodynamically significant dysrhythmias.
  • pre-existing atrial fibrillation or high degree AV (atrioventricular block).
  • pacemaker dependency.
  • known sensitivity to beta blockers.
  • patient refusal.

Treatment and study plan

Nitroglycerin

Drug

nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.

esmolol

Drug

esmolol will be administered by infusion following a step up / step down protocol to control hypertension.

Primary outcomes

  1. Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour

    Time frame: Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours

    Area under the curve (AUC) of Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass

Secondary outcomes

  1. Title: Systolic Hypertension

    Time frame: Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours

    Area under the curve (AUC) of Systolic Blood Pressure Excursions Beyond Predetermined Upper Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass(CPB) in Cardiac Surgery: a Randomized, Controlled Trial

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 1, 2010
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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